FDA-Drug2022-08-24Class II

PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33

Nephron Sterile Compounding Center LLC
Hazard

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Sold states
Nationwide in the USA
Affected count
13,500 vials
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1344-2022

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